FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations
The U.S. Food and Drug Administration (FDA) released an updated guidance docume [...]
5
08, 2025
24
10, 2024
5 Places to Use a FMEA in Your Quality Process
Before any road trip, it makes sense to check your tire pressure along with lev [...]
25
04, 2023
Update: EU Medical Device Regulation Deadlines Extended
European Union (EU) Medical Device Regulation (MDR) and In-Vitro Device Regulati [...]
3
01, 2023
Root Cause Analysis Tools: Which Should You Use?
Root cause analysis is a common weak spot in manufacturing, causing numerous qua [...]
2
11, 2022
Finding the Root Cause: Where Manufacturers Go Wrong
Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]
12
10, 2022
5 Strategies to Improve Quality Incident Management and Root Cause Analysis
Imagine you’re doing a pre-shipment inspection on multiple pallets containing pr [...]
30
11, 2021
How to use Decision Trees for Root Cause Analysis
Let's start with a scenario that illustrates the methodology behind using decisi [...]
10
11, 2021
How to Use FMEA for Root Cause Analysis
Imagine that you’re a manufacturer of skincare products detecting a spike in co [...]
14
10, 2021
How to Use the 5 Whys for Root Cause Analysis
Solving problems that occur on the manufacturing floor is a lot like peeling an [...]
